Labor Induction versus Expectant Management in Low-Risk Nulliparous Women.
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ABSTRACT:
SUBMITTER: Grobman WA
PROVIDER: S-EPMC6186292 | biostudies-literature | 2018 Aug
REPOSITORIES: biostudies-literature
Publications
Labor Induction versus Expectant Management in Low-Risk Nulliparous Women.
Grobman William A WA Rice Madeline M MM Reddy Uma M UM Tita Alan T N ATN Silver Robert M RM Mallett Gail G Hill Kim K Thom Elizabeth A EA El-Sayed Yasser Y YY Perez-Delboy Annette A Rouse Dwight J DJ Saade George R GR Boggess Kim A KA Chauhan Suneet P SP Iams Jay D JD Chien Edward K EK Casey Brian M BM Gibbs Ronald S RS Srinivas Sindhu K SK Swamy Geeta K GK Simhan Hyagriv N HN Macones George A GA
The New England journal of medicine 20180801 6
<h4>Background</h4>The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain.<h4>Methods</h4>In this multicenter trial, we randomly assigned low-risk nulliparous women who were at 38 weeks 0 days to 38 weeks 6 days of gestation to labor induction at 39 weeks 0 days to 39 weeks 4 days or to expectant management. The primary outcome was a composite of perinatal death or severe neonatal complications; the principal secondary outcome was ...[more]
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Project description:BackgroundThere is no apparent consensus on obstetric management, i.e., induction of labor or expectant management of women with suspected large-for-gestational-age (LGA)-fetuses.Methods and findingsTo further examine the subject, a nationwide population-based cohort study from the Swedish Medical Birth Register in nulliparous non-diabetic women with singleton, vertex LGA (>90th centile) births, 1992-2013, was performed. Delivery of a live-born LGA infant induced at 38 completed weeks of gestation in non-preeclamptic pregnancies, was compared to those of expectant management, with delivery at 39, 40, 41, or 42 completed weeks of gestation and beyond, either by labor induction or via spontaneous labor. Primary outcome was mode of delivery. Secondary outcomes included obstetric anal sphincter injury, 5-minute Apgar<7 and birth injury. Multivariable logistic regression analysis was performed to control for potential confounding. We found that among the 722 women induced at week 38, there was a significantly increased risk of cesarean delivery (aOR = 1.44 95% CI:1.20-1.72), compared to those with expectant management (n = 44 081). There was no significant difference between the groups in regards to risk of instrumental vaginal delivery (aOR = 1.05, 95% CI:0.85-1.30), obstetric anal sphincter injury (aOR = 0.81, 95% CI:0.55-1.19), nor 5-minute Apgar<7 (aOR = 1.06, 95% CI:0.58-1.94) or birth injury (aOR = 0.82, 95% CI:0.49-1.38). Similar comparisons for induction of labor at 39, 40 or 41 weeks compared to expectant management with delivery at a later gestational age, showed increased rates of cesarean delivery for induced women.ConclusionsIn women with LGA infants, induction of labor at 38 weeks gestation is associated with increased risk of cesarean delivery compared to expectant management, with no difference in neonatal morbidity.
| S-EPMC5519027 | biostudies-literature
Project description:ObjectiveTo compare the actual health-system cost of elective labor induction at 39 weeks of gestation with expectant management.MethodsThis was an economic analysis of patients enrolled in the five Utah hospitals participating in a multicenter randomized trial of elective labor induction at 39 weeks of gestation compared with expectant management in low-risk nulliparous women. The entire trial enrolled more than 6,000 patients. For this subset, 1,201 had cost data available. The primary outcome was relative direct health care costs of maternal and neonatal care from a health system perspective. Secondary outcomes included the costs of each phase of maternal and neonatal care. Direct health system costs of maternal and neonatal care were measured using advanced costing analytics from the time of randomization at 38 weeks of gestation until exit from the study up to 8 weeks postpartum. Costs in each randomization arm were compared using generalized linear models and reported as the relative cost of induction compared with expectant management. With a fixed sample size, we had adequate power to detect a 7.3% or greater difference in overall costs.ResultsThe total cost of elective induction was no different than expectant management (mean difference +4.7%; 95% CI -2.1% to +12.0%; P=.18). Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001). Maternal inpatient intrapartum and delivery care costs, conversely, were 16.9% higher among women undergoing labor induction (95% CI +5.5% to +29.5%; P=.003). Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge did not differ between arms.ConclusionTotal costs of elective labor induction and expectant management did not differ significantly. These results challenge the assumption that elective induction of labor leads to significant cost escalation.
| S-EPMC7323797 | biostudies-literature
Project description:ObjectiveTo evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.MethodsWe conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested.ResultsOf 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05).ConclusionCompared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups.Clinical trial registrationClinicalTrials.gov, NCT01990612.
| S-EPMC7529933 | biostudies-literature
Project description:BackgroundAlthough induction of labor of low-risk nulliparous women at 39 weeks reduces the risk of cesarean delivery compared with expectant management, concern regarding more frequent use of labor induction remains, given that this intervention historically has been thought to incur greater resource utilization.ObjectiveThe objective of the study was to determine whether planned elective labor induction at 39 weeks among low-risk nulliparous women, compared with expectant management, was associated with differences in health care resource utilization from the time of randomization through 8 weeks postpartum.Study designThis is a planned secondary analysis of a multicenter randomized trial in which low-risk nulliparous women were assigned to induction of labor at 39 weeks or expectant management. We assessed resource utilization after randomization in 3 time periods: antepartum, delivery admission, and discharge through 8 weeks postpartum.ResultsOf 6096 women with data available, those in the induction of labor group (n = 3059) were significantly less likely in the antepartum period after randomization to have at least 1 ambulatory visit for routine prenatal care (32.4% vs 68.4%), unanticipated care (0.5% vs 2.6%), or urgent care (16.2% vs 44.3%), or at least 1 antepartum hospitalization (0.8% vs 2.2%, P < .001 for all). They also had fewer tests (eg, sonograms, blood tests) and treatments (eg, antibiotics, intravenous hydration) prior to delivery. During the delivery admission, women in the induction of labor group spent a longer time in labor and delivery (median, 0.83 vs 0.57 days), but both women (P = .002) and their neonates (P < .001) had shorter postpartum stays. Women and neonates in both groups had similar frequencies of postpartum urgent care and hospital readmissions (P > .05 for all).ConclusionWomen randomized to induction of labor had longer durations in labor and delivery but significantly fewer antepartum visits, tests, and treatments and shorter maternal and neonatal hospital durations after delivery. These results demonstrate that the health outcome advantages associated with induction of labor are gained without incurring uniformly greater health care resource use.
| S-EPMC7141954 | biostudies-literature
Project description:ObjectiveTo develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation.MethodsWe conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor.ResultsOf 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management.ConclusionIrrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their "customized" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation.Clinical trial registrationClinicalTrials.gov, NCT01990612.
| S-EPMC7899015 | biostudies-literature
Project description:ObjectiveTo compare risks of maternal and perinatal outcomes by completed week of gestation from 39 weeks in low-risk nulliparous patients undergoing expectant management.MethodsWe conducted a secondary analysis of a multicenter randomized trial of elective induction of labor at 39 weeks of gestation compared with expectant management in low-risk nulliparous patients. Participants with nonanomalous neonates, who were randomized to and underwent expectant management and attained 39 0/7 weeks of gestation, were included. Delivery gestation was categorized by completed week: 39 0/7-39 6/7 (39 weeks), 40 0/7-40 6/7 (40 weeks), and 41 0/7-42 2/7 (41-42 weeks) (none delivered after 42 2/7). The coprimary outcomes were cesarean delivery and a perinatal composite (death, respiratory support, 5-minute Apgar score 3 or less, hypoxic ischemic encephalopathy, seizure, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support). Other outcomes included a maternal composite (blood transfusion, surgical intervention for postpartum hemorrhage, or intensive care unit admission), hypertensive disorders of pregnancy, peripartum infection, and neonatal intermediate or intensive care unit admission. For multivariable analysis, P<.0125 was considered to indicate statistical significance for the coprimary outcomes.ResultsOf 2,502 participants who underwent expectant management, 964 (38.5%) delivered at 39 weeks of gestation, 1,111 (44.4%) at 40 weeks, and 427 (17.1%) at 41-42 weeks. The prevalence of medically indicated delivery was 37.9% overall and increased from 23.8% at 39 weeks of gestation to 80.3% at 41-42 weeks. The frequency of cesarean delivery (17.3%, 22.0%, 37.5%; P<.001) and the perinatal composite (5.1%, 5.9%, 8.2%; P=.03) increased with 39, 40, and 41-42 weeks of gestation, respectively, and hypertensive disorders of pregnancy decreased (16.4%, 12.1%, 10.8%, P=.001). The adjusted relative risk, 95% CI (39 weeks as referent) was significant for cesarean delivery at 41-42 weeks of gestation (1.93, 1.61-2.32) and for hypertensive disorders of pregnancy at 40 weeks (0.71, 0.58-0.88) and 41-42 weeks (0.61, 0.45-0.82). None of the other outcomes were significant.ConclusionIn expectantly managed low-risk nulliparous participants, the frequency of medically indicated induction of labor, and the risks of cesarean delivery but not the perinatal composite outcome, increased significantly from 39 to 42 weeks of gestation.
| S-EPMC8404416 | biostudies-literature
Project description:A recent randomised controlled trial (RCT) demonstrated that induction of labour at 39 weeks of gestational age has no short-term adverse effect on the mother or infant among nulliparous women aged ?35 years. However, the trial was underpowered to address the effect of routine induction of labour on the risk of perinatal death. We aimed to determine the association between induction of labour at ?39 weeks and the risk of perinatal mortality among nulliparous women aged ?35 years.We used English Hospital Episode Statistics (HES) data collected between April 2009 and March 2014 to compare perinatal mortality between induction of labour at 39, 40, and 41 weeks of gestation and expectant management (continuation of pregnancy to either spontaneous labour, induction of labour, or caesarean section at a later gestation). Analysis was by multivariable Poisson regression with adjustment for maternal characteristics and pregnancy-related conditions. Among the cohort of 77,327 nulliparous women aged 35 to 50 years delivering a singleton infant, 33.1% had labour induced: these women tended to be older and more likely to have medical complications of pregnancy, and the infants were more likely to be small for gestational age. Induction of labour at 40 weeks (compared with expectant management) was associated with a lower risk of in-hospital perinatal death (0.08% versus 0.26%; adjusted risk ratio [adjRR] 0.33; 95% CI 0.13-0.80, P = 0.015) and meconium aspiration syndrome (0.44% versus 0.86%; adjRR 0.52; 95% CI 0.35-0.78, P = 0.002). Induction at 40 weeks was also associated with a slightly increased risk of instrumental vaginal delivery (adjRR 1.06; 95% CI 1.01-1.11, P = 0.020) and emergency caesarean section (adjRR 1.05; 95% CI 1.01-1.09, P = 0.019). The number needed to treat (NNT) analysis indicated that 562 (95% CI 366-1,210) inductions of labour at 40 weeks would be required to prevent 1 perinatal death. Limitations of the study include the reliance on observational data in which gestational age is recorded in weeks rather than days. There is also the potential for unmeasured confounders and under-recording of induction of labour or perinatal death in the dataset.Bringing forward the routine offer of induction of labour from the current recommendation of 41-42 weeks to 40 weeks of gestation in nulliparous women aged ?35 years may reduce overall rates of perinatal death.
| S-EPMC5685438 | biostudies-literature
Project description:IntroductionObesity is associated with many pregnancy complications, including both fetal macrosomia and prolonged labour. As a result, there is often also an increased risk of caesarean section. In other settings, labour induction near to term reduces adverse outcomes such as stillbirth and birth injury, without causing more caesarean deliveries. It has been suggested that induction will reduce adverse events in this setting too, but there have been no trials and the effect on caesarean section is unknown. The objective of this study is to compare induction of labour in gestational week 39 with expectant management on the risk of caesarean section in women with body mass index ≥30 kg/m2.Methods and analysisAn open label randomised controlled multicentre trial are conducted at Danish delivery departments with an in-house neonatal intensive care unit. Recruitment started October 2020. A total of 1900 women with a prepregnancy body mass index ≥30 kg/m2 are randomised in a 1:1 ratio to either labour induction at 39 weeks and 0 to 3 days of gestation or to expectant management; that is, waiting for spontaneous labour onset or induction if medically indicated. The primary outcome is caesarean section. Data will be analysed according to intention-to-treat.Ethics and disseminationThe Central Denmark Region Committee on Biomedical Research Ethics approved the study. The study is conducted in accordance with the ethical principles outlined in the latest version of the 'Declaration of Helsinki' and the 'Guideline for Good Clinical Practice' related to experiments on humans. The trial findings will be disseminated to participants, clinicians, commissioning groups and via peer-reviewed publications.Trial registration numberNCT04603859.
| S-EPMC9039382 | biostudies-literature
Project description:BackgroundAt present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term.Methods and findingsWe conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34(+0) and 37(+0) wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM.ConclusionsIn women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM.Trial registrationCurrent Controlled Trials ISRCTN29313500
| S-EPMC3335867 | biostudies-literature
Project description:ObjectiveOptimal management of pregnancies at 39 weeks gestational age is unknown. Therefore, we sought to perform a comparative effectiveness analysis of elective induction of labor (eIOL) at 39 weeks among nulliparous women with non-anomalous singleton, vertex fetuses as compared to expectant management (EM) which included IOL for medical or obstetric indications or at 41 weeks in undelivered mothers.Materials and methodsA Monte Carlo micro-simulation model was constructed modeling two mutually exclusive health states: eIOL at 39 weeks, or EM with IOL for standard medical or obstetrical indications or at 41 weeks if undelivered. Health state distribution probabilities included maternal and perinatal outcomes and were informed by a review of the literature and data derived from the Consortium of Safe Labor. Analyses investigating preferences for maternal versus infant health were performed using weighted utilities. Primary outcome was determining which management strategy posed less maternal and neonatal risk. Secondary outcomes were rates of cesarean deliveries, maternal morbidity and mortality, stillbirth, neonatal morbidity and mortality, and preferences regarding the importance of maternal and perinatal health.ResultsA management strategy of eIOL at 39 weeks resulted in less maternal and neonatal risk as compared to EM with IOL at 41 weeks among undelivered patients. Cesarean section rates were higher in the EM arm (35.9% versus 13.9%, p<0.01). When analysis was performed only on patients with an unfavorable cervix, 39 week eIOL still resulted in fewer cesarean deliveries as compared to EM (8.0% versus 26.1%, p<0.01). There was no statistical difference in maternal mortality (eIOL 0% versus EM 0.01%, p = 0.32) but there was an increase in maternal morbidity among the EM arm (21.2% versus 16.5, p<0.01). There were more stillbirths (0.13% versus 0%, p<0.0003), neonatal deaths (0.25% versus 0.12%, p< 0.03), and neonatal morbidity (12.1% versus 9.4%, p<0.01) in the EM arm as compared to the eIOL arm. Preference modeling revealed that 39 week eIOL was favored over EM.Conclusions and relevanceMathematical modeling revealed that eIOL at 39 weeks resulted in lower population risks as compared to EM with induction of labor at 41 weeks. Specifically, eIOL at 39 weeks resulted in a lower cesarean section rate, lower rates of maternal morbidity, fewer stillbirths and neonatal deaths, and lower rates of neonatal morbidity.
| S-EPMC5918610 | biostudies-literature